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An Open-label Dose Escalation and Expansion, Followed by a Phase II Study of Tulmimetostat (DZR123) and JSB462 (Luxdegalutamide) in Patients With Progressive Metastatic Castrate Resistant Prostate Cancer (mCRPC) (TulmiSTAR-01)

NCT07206056 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2026-05-08

No results posted yet for this study

Summary

This is a two-part, Phase I/II, open-label, global, multicenter study assessing the safety and efficacy of the combination of tulmimetostat (DZR123) and JSB462 (luxdegalutamide) versus standard of care in participants with progressive metastatic castrate resistant prostate cancer (mCRPC).

Conditions

  • Progressive Metastatic Castrate Resistant Prostate Cancer

Interventions

DRUG

Tulmimetostat DL1 QD

Part 1a (dose escalation): Doses of tulmimetostat beyond DL1 once a day (QD) will be opened depending on outcome of Dose Escalation Meetings (DEM(s))

DRUG

Tulmimetostat DL2 QD

Part 1a (dose escalation): Doses of tulmimetostat beyond DL1 once a day (QD) will be opened depending on outcome of Dose Escalation Meetings (DEM(s))

DRUG

Tulmimetostat DL3 QD

Part 1a (dose escalation): Doses of tulmimetostat beyond DL1 once a day (QD) will be opened depending on outcome of Dose Escalation Meetings (DEM(s))

DRUG

Tulmimetostat Doses 1 or 2 QD

Part 1b (dose expansion and optimization): tulmimetostat doses 1 or 2 QD

DRUG

Tulmimetostat RP2D QD

Part 2: tulmimetostat Recommended Phase 2 Dose (RP2D) QD

DRUG

JSB462 Dose 1 QD

JSB462 Dose 1 QD

DRUG

JSB462 Dose 2 QD

JSB462 Dose 2 QD

DRUG

JSB462 QD

The dose of JSB462 QD will be determined based on the totality of data from Part 1a

DRUG

Standard of Care (SoC)

Androgen Receptor Pathway Inhibitors (ARPI), chemotherapy or Pluvicto (AAA617) at the discretion of the investigator

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-15
Primary Completion
2029-11-09
Completion
2030-12-01
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • China
  • Denmark
  • France
  • Germany
  • Italy
  • Malaysia
  • Poland
  • Singapore
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07206056 on ClinicalTrials.gov